Fibrostenotic Crohn's DiseasePhase 2NCT05843578
STENOVA - A Study to Evaluate Safety, Tolerability, PK and PD of AGMB-129 in Patients With Fibrostenotic Crohn's Disease
A Phase 2 study testing AGMB-129 in people with Fibrostenotic Crohn's Disease, run by Agomab Spain S.L.U. at 52 sites in 8 countries.
Trial summary
Many patients with Crohn's disease develop fibrotic narrowing (strictures) in their bowel, causing obstructive symptoms such as abdominal pain, cramping, or vomiting after meals. Because of these symptoms, patients often require bowel resection surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrostenotic Crohn's Disease
- What is being tested?
- AGMB-129
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 52 sitesin 8 countries
- Study dates
- 1 Aug 2023to 20 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ileal or ileocolonic CD based on supporting guideline criteria (eg, clinical, endoscopic, and histologic evidence) established at least 3 months prior to screening.
- Presence of at least 1 stricture in the terminal ileum within reach of an endoscope (passable or nonpassable).Strictures should be noncritical, naïve or anastomotic stricture(s), caused by CD and confirmed centrally by MRE according to the following criteria:
- Localized luminal narrowing (luminal diameter ≤50% relative to normal adjacent bowel); AND
- Bowel wall thickening (≥25% relative to adjacent bowel; AND
- Either prestenotic dilation (defined as a luminal diameter ≥3 cm) or nonpassable with adult colonoscope
- Presence of tolerable obstructive symptoms, as defined by a screening S-PRO severity score ≥2, and not expected to require hospitalization, endoscopic balloon dilation, surgical resection, or additional therapy during the study. Participant should have sufficient food intake, even with diet modification.
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- Stable background therapy for CD and agree to maintain background therapy for the study duration
- Completion of the 12-week treatment period (Part A) and participant is willing and able to continue treatment.
- Per investigator judgment, participant is able to continue or resume treatment following completion of the Week 12 visit in Part A.
Who cannot join
- History or current diagnosis of ulcerative colitis, indeterminate colitis, ischemic colitis, nonsteroidal anti-inflammatory drug-induced colitis, idiopathic colitis (ie, colitis not consistent with CD), radiation colitis, microscopic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption.
- CD-related complications (previous extensive small bowel resection, ileorectal anastomosis, proctocolectomy, short bowel syndrome, ileostomy [diverting or end], colostomy, small bowel stoma, ileoanal pouch, inactive fistulae in or adjacent to an ileal stricture, anal and perianal stricture, active intra-abdominal or perianal abscess that has not been appropriately treated, abscess in relation to the stricture, toxic megacolon, very severe inflammation, or presence of deep ulceration in the colon or terminal ileum).
- Ileitis not associated with CD (eg, ileitis associated with infections, spondyloarthropathies, ischemia, etc.).
- Endoscopic balloon dilation or surgical treatment of the same small bowel stricture within the last 6 months prior to screening
- Receiving cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks of screening or Janus kinase inhibitor therapy within 4 weeks of screening.
- Requiring continued treatment with systemically administered medications that are sensitive CYP3A4/5 substrates with a narrow therapeutic index or strong inhibitors of aldehyde oxidase or xanthine oxidase.
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- Current or history of vasculitis, valvulopathy or large vessel disorder or major abnormalities documented by cardiac echocardiography with Doppler
- More than 24 weeks since completion of the Week 12 visit in Part A.
- Experienced any AE leading to permanent treatment discontinuation during treatment with study drug in the double blind treatment period (Part A).
- Have undergone endoscopic balloon dilation or bowel surgery (resection surgery or strictureplasty) for any intestinal stricture since the Week 12 visit in Part A.
- Developed any condition which meets the Part A exclusion criteria, as per investigator judgment.
- Any condition which in the opinion of the investigator affects the safety or ability to participate in Part B.
- Participation in any other clinical trial since the completion of the Week 12 visit in Part A.
Trial locations and contacts
52 sites in 8 countries.
52 sites in 8 countries
United States11 sites
University of Michigan
Ann Arbor, Michigan, 48109
Cleveland Clinic
Cleveland, Ohio, 44195
Gastro One
Cordova, Tennessee, 38018
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518
Gastroenterology Health Partners
Louisville, Kentucky, 40218
University of Miami
Miami, Florida, 33136
Gastroenterology Health Partners
New Albany, Indiana, 47150
Digestive and Liver Center of Florida
Orlando, Florida, 32825
Mayo Clinic
Rochester, Minnesota, 55905
Louisiana Research Center
Shreveport, Louisiana, 71105
Washington University School of Medicine
St Louis, Missouri, 63110
Poland11 sites
Specialist Gastrology Centre GASTROMED
Bialystok
Vita Longa Sp. z.o.o.
Katowice, 40-748
MEDRISE Sp. z o.o.
Lublin, 20-582
SOLUMED Medical Center
Poznan
Endoskopia Sp. z o.o.
Sopot
H-T. Medical Center
Tychy
WIP Warsaw IBD Point
Warsaw, 00-728
WSD Medi Clinical Sp. z o.o.
Warsaw
Planetmed Sp. z o.o.
Wroclaw, 52210
VISTAMED
Wroclaw
ETG Zamość
Zamość, 22-400
Canada7 sites
University of Calgary
Calgary, AB T2N 4Z6
Gastroenterology and Internal Medicine Research Institute (GIRI)
Edmonton, T5R1W2
South Edmonton Gastroenterology Research Clinic
Edmonton, T6K 4B2
Nova Scotia Health Authority
Halifax
TIDHI Innovation Inc.
North York, ON M6A 3B4
Ottawa Hospital Research Institute
Ottawa
(G.I.R.I) GI Research Institute
Vancouver, BC V6Z 2K5
Italy7 sites
University Polyclinic Hospital "G. Martino"
Messina
Humanitas Research Hospital IRCCS Istituto Clinico Humanitas
Milan, 20089
Hospital San Raffaele
Milan
Azienda Ospedaliero Universitaria di Modena - Struttura Complessa di Gastroenterologia
Modena, 41124
Sacred Heart Don Calabria
Negrar
Azienda Ospedaliera San Camillo Forlanini
Rome, 00152
University Polyclinic Foundation "Agostino Gemelli"
Rome
Denmark5 sites
Aarhus University Hospital, Department of Hepatology and Gastroenterology
Aarhus
Bispebjerg Hospital
Copenhagen, 2400
Rigshospitalet - University Hospital Copenhagen
Copenhagen
Herlev Hospital (University of Copenhagen)
Herlev, 2730
Odense University Hospital
Odense, 5000
Austria4 sites
Medical University of Graz
Graz, 8036
Gemeinnutzige Salzburger Landeskliniken Betriebsgesellschaft mbH (Landeskrankenhaus Salzburg/Regional Hospital Salzburg)
Salzburg, 5020
Medical University Of Vienna (AKH Wien)
Vienna, 1090
Hospital Landstrasse, Department of Internal Medicine IV
Vienna
Germany4 sites
Charite Universitatsmedizin Berlin KöR Campus Benjamin Franklin Medizinische
Berlin, 12203/12200
Servicegesellschaft Krankenhaus Waldfriede mbH Krankenhaus Waldfriede e.V Akademisches Lehrkrankenhaus der Charite
Berlin, 14163
BSF Studiengesellschaft UG (Unternehmergesellschaft, haftungsbeschränkt)
Halle, 06108
Universitatsklinikum Ulm AöR (University of Ulm)
Ulm, 89081
Spain3 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitario de Gran Canaria
Las Palmas de Gran Canaria, 35010
Hospital Universitario Virgen del Rocio
Seville, 41013
About this study
Official title: A Phase 2a, Randomized, Placebo-controlled, Double-blind Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AGMB-129 in Patients With Fibrostenotic Crohn's Disease
Many patients with Crohn's disease develop fibrotic narrowing (strictures) in their bowel, causing obstructive symptoms such as abdominal pain, cramping, or vomiting after meals. Because of these symptoms, patients often require bowel resection surgery. The objective of this clinical trial is to evaluate the safety, pharmacokinetics, and pharmacodynamics of AGMB-129 (Ontunisertib) in patients with Crohn's disease and symptomatic strictures, and whether it can have a beneficial effect on intestinal strictures.
The participants will be in the Part A for a duration of up to 19 weeks including a 5 week screening period, a 12-week double-blind, placebo-controlled treatment period, and 2 week safety follow up period. Participants who continue to Part B can receive treatment for up to an additional 48 weeks, with a safety follow-up visit 2 weeks after the last dose of treatment.
Read the detailed description
Part A is a randomized, placebo-controlled, double-blind, parallel, multicenter, phase 2a study in participants with Crohn's disease and symptomatic intestinal strictures.
Part A consists of 3 periods (a screening period, a placebo-controlled, double-blind treatment period, and safety follow-up). After signing informed consent, eligibility will be assessed during a 5-week screening period. The presence of qualifying intestinal strictures will be assessed by ileocolonoscopy and magnetic resonance enterography (MRE). The presence of obstructive symptoms will be also evaluated.
Eligible participants will be randomized 1:1:1 to receive AGMB-129 high dose, low dose or placebo for 12 weeks.
During Screening and Week 12 visits, participants will undergo ileocolonoscopy with biopsy collection for exploring pharmacodynamics. Participants will have blood sample collection at Weeks 2, 4, 8, and 12 to assess safety, pharmacokinetics, and pharmacodynamics.
Throughout the study, participants will undergo routine safety assessments at study visits, which will include physical examination, vital signs, clinical laboratory assessment, electrocardiogram (ECG), and recording of AEs.
Part B is an open-label treatment extension for participants who have completed the double-blind treatment period in Part A.
- Conditions
- Fibrostenotic Crohn's Disease
- Being tested
- AGMB-129, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGMB-129Drug
Oral capsule
PlaceboDrug
Matching oral capsule
| Study group | Role | What they receive |
|---|---|---|
| AGMB-129 High | Experimental | AGMB-129 high dose Receives: Drug: AGMB-129 |
| AGMB-129 Low | Experimental | AGMB-129 low dose Receives: Drug: AGMB-129 |
| Placebo | Experimental | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (Part A and B)
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of adverse events at every visit
Measured: From Screening to Week 48
Number of participants with abnormal clinical laboratory values (Part A and B)
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of abnormal laboratory parameters at every visit
Measured: From Screening to Week 48
Number of participants with abnormal ECG parameters (Part A and B)
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of abnormal ECG parameters at every visit
Measured: From Screening to Week 48
Number of participants with abnormal vital signs (Part A and B)
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of vital signs at every visit
Measured: From Screening to Week 48
Number of participants with abnormal physical exams (Part A and B)
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of physical exams at every visit
Measured: From Screening to Week 48
Number of participants with abnormal 2D-echocardiography (Part A and B)
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of echocardiography at week 12
Measured: From Screening to Week 48
Secondary outcomes (2)
Plasma levels of AGMB-129 and its metabolites (Part A and B)
To characterize the pharmacokinetics (PK) of AGMB-129 and its metabolites by measuring the amount in plasma
Measured: From Baseline to Week 48
Changes in mRNA gene expression in ileal biopsies ((Part A)
To characterize the pharmacodynamics of AGMB-129 by determining the gene expression in ileal biopsies
Measured: From Baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Aug 2023
- Primary completion20 Jun 2026
- Study completion20 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrostenotic Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled, double-blind, parallel, multicenter, phase 2a study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agomab Spain S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Wiesel, MD, Study director, Agomab Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843578
- Sponsor's protocol ID
- AGMB-129-C102
- Status last verified
- Jul 2026
- First submitted
- 25 Apr 2023
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Placebo-controlled, Double-blind Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AGMB-129 in Patients With Fibrostenotic Crohn's Disease
- ClinicalTrials.gov ID
- NCT05843578
- Acronym / sponsor ID
- AGMB-129-C102
- Conditions
- Fibrostenotic Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Agomab Spain S.L.U.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 20 Jun 2026 (actual)
- Study completion
- 20 Jun 2026 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many patients with Crohn's disease develop fibrotic narrowing (strictures) in their bowel, causing obstructive symptoms such as abdominal pain, cramping, or vomiting after meals. Because of these symptoms, patients often require bowel resection surgery. The objective of this clinical trial is to evaluate the safety, pharmacokinetics, and pharmacodynamics of AGMB-129 (Ontunisertib) in patients with Crohn's disease and symptomatic strictures, and whether it can have a beneficial effect on intestinal strictures.
The participants will be in the Part A for a duration of up to 19 weeks including a 5 week screening period, a 12-week double-blind, placebo-controlled treatment period, and 2 week safety follow up period. Participants who continue to Part B can receive treatment for up to an additional 48 weeks, with a safety follow-up visit 2 weeks after the last dose of treatment.
Detailed description
Part A is a randomized, placebo-controlled, double-blind, parallel, multicenter, phase 2a study in participants with Crohn's disease and symptomatic intestinal strictures.
Part A consists of 3 periods (a screening period, a placebo-controlled, double-blind treatment period, and safety follow-up). After signing informed consent, eligibility will be assessed during a 5-week screening period. The presence of qualifying intestinal strictures will be assessed by ileocolonoscopy and magnetic resonance enterography (MRE). The presence of obstructive symptoms will be also evaluated.
Eligible participants will be randomized 1:1:1 to receive AGMB-129 high dose, low dose or placebo for 12 weeks.
During Screening and Week 12 visits, participants will undergo ileocolonoscopy with biopsy collection for exploring pharmacodynamics. Participants will have blood sample collection at Weeks 2, 4, 8, and 12 to assess safety, pharmacokinetics, and pharmacodynamics.
Throughout the study, participants will undergo routine safety assessments at study visits, which will include physical examination, vital signs, clinical laboratory assessment, electrocardiogram (ECG), and recording of AEs.
Part B is an open-label treatment extension for participants who have completed the double-blind treatment period in Part A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, placebo-controlled, double-blind, parallel, multicenter, phase 2a study
| Arm | Type | Receives |
|---|---|---|
| AGMB-129 High | Experimental | Drug: AGMB-129AGMB-129 high dose |
| AGMB-129 Low | Experimental | Drug: AGMB-129AGMB-129 low dose |
| Placebo | Experimental | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of ileal or ileocolonic CD based on supporting guideline criteria (eg, clinical, endoscopic, and histologic evidence) established at least 3 months prior to screening.
- Presence of at least 1 stricture in the terminal ileum within reach of an endoscope (passable or nonpassable).Strictures should be noncritical, naïve or anastomotic stricture(s), caused by CD and confirmed centrally by MRE according to the following criteria:
- Presence of tolerable obstructive symptoms, as defined by a screening S-PRO severity score ≥2, and not expected to require hospitalization, endoscopic balloon dilation, surgical resection, or additional therapy during the study. Participant should have sufficient food intake, even with diet modification.
- Stable background therapy for CD and agree to maintain background therapy for the study duration
- Completion of the 12-week treatment period (Part A) and participant is willing and able to continue treatment.
Key exclusion criteria (13 listed)
- History or current diagnosis of ulcerative colitis, indeterminate colitis, ischemic colitis, nonsteroidal anti-inflammatory drug-induced colitis, idiopathic colitis (ie, colitis not consistent with CD), radiation colitis, microscopic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption.
- CD-related complications (previous extensive small bowel resection, ileorectal anastomosis, proctocolectomy, short bowel syndrome, ileostomy [diverting or end], colostomy, small bowel stoma, ileoanal pouch, inactive fistulae in or adjacent to an ileal stricture, anal and perianal stricture, active intra-abdominal or perianal abscess that has not been appropriately treated, abscess in relation to the stricture, toxic megacolon, very severe inflammation, or presence of deep ulceration in the colon or terminal ileum).
- Ileitis not associated with CD (eg, ileitis associated with infections, spondyloarthropathies, ischemia, etc.).
- Endoscopic balloon dilation or surgical treatment of the same small bowel stricture within the last 6 months prior to screening
- Receiving cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks of screening or Janus kinase inhibitor therapy within 4 weeks of screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGMB-129Oral capsule | Drug | AGMB-129 High, AGMB-129 Low |
| PlaceboMatching oral capsule | Drug | Placebo |
Primary outcome
Number of participants with adverse events (Part A and B)
Time frame: From Screening to Week 48
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of adverse events at every visit
Number of participants with abnormal clinical laboratory values (Part A and B)
Time frame: From Screening to Week 48
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of abnormal laboratory parameters at every visit
Number of participants with abnormal ECG parameters (Part A and B)
Time frame: From Screening to Week 48
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of abnormal ECG parameters at every visit
Number of participants with abnormal vital signs (Part A and B)
Time frame: From Screening to Week 48
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of vital signs at every visit
Number of participants with abnormal physical exams (Part A and B)
Time frame: From Screening to Week 48
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of physical exams at every visit
Number of participants with abnormal 2D-echocardiography (Part A and B)
Time frame: From Screening to Week 48
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of echocardiography at week 12
2 secondary outcomes
Plasma levels of AGMB-129 and its metabolites (Part A and B)
Time frame: From Baseline to Week 48
Changes in mRNA gene expression in ileal biopsies ((Part A)
Time frame: From Baseline to Week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Wiesel, MD study director
Agomab Therapeutics
52 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AGMB-129 in people with Fibrostenotic Crohn's Disease, run by Agomab Spain S.L.U. at 52 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Poland, Canada, Italy, Denmark and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (Part A and B) (time frame: From Screening to Week 48). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.